Plication tagging device and method

Abstract

An improvement in a stapling device and method designed to capture a tissue fold between first and second members in the device and to staple and cut the fold to form a stapled tissue plication with a hole therein is disclosed. The improvement includes an engagement assembly in the first member movable from a retracted position in the first member to an extended position in the second member, and releasably attached to second member, an anchor assembly that includes the anchor, wherein (i) movement of the engagement assembly from its retracted to its extended position, through a tissue fold captured in the device between the first and second device members, is operable to engage the anchor assembly, and (ii) movement of the engagement assembly, with the anchor assembly engaged therewith, back toward its retracted position, is effective to pull at least a portion of the assembly through the hole in the stapled tissue plication formed by the device.

1 . In a stapling device designed to capture a tissue fold between first and second members in the device and to staple and cut the fold to form a stapled tissue plication with a hole therein, an improvement for placing in the stapled tissue plication, an anchor effective to attach an implant device to the tissue fold, comprising
 an engagement assembly in the first member movable from a retracted position in the first member to an extended position in the second member, and   releasably attached to second member, an anchor assembly that includes the anchor,   wherein (i) movement of the engagement assembly from its retracted to its extended position, through a tissue fold captured in the device between the first and second device members, is operable to engage the anchor assembly, and (ii) movement of the engagement assembly, with the anchor assembly engaged therewith, back toward its retracted position, is effective to pull at least a portion of the assembly through the hole in the stapled tissue plication formed by the device.   
     
     
         2 . The improvement of  claim 1 , wherein the first member includes a housing and a drive piston movable within the housing from a retracted position to an extended position and a tissue cutter, the engagement assembly includes an engagement pin, the cutter and pin are attached to the drive piston for movement therewith, and movement of the drive piston from its retracted to its extended position is operable to (i) drive the pin through a tissue fold captured in the device, (ii) form a hole in the tissue fold, and (iii) engage the pin with the anchor assembly. 
     
     
         3 . The improvement of  claim 2 , wherein the first member includes a staple holder having a first tissue-contact surface adapted to contact one face of a captured tissue fold and a staple pusher attached to the drive piston for movement therewith within the first-member housing, and movement of the drive piston from its retracted to its extended position is operable to (i) staple the tissue fold captured in the device, (ii) drive the pin through a fold, (iii) form a hole in the tissue fold, and (iv) engage the pin with the anchor assembly. 
     
     
         4 . The improvement of  claim 3 , wherein the second member includes a housing, an anvil attached to the housing and having a second tissue-contact surface adapted to contact the other face of a captured tissue fold, and a cutter board mounted adjacent the anvil, against which the cutter is pressed when the cutter is moved to its second position, to cut a hole in a tissue fold captured between the tissue-contact surfaces of the staple holder and anvil. 
     
     
         5 . The improvement of  claim 4 , wherein the anchor assembly includes (i) a pin-engaging plug mounted releasably on the second-member housing adjacent the cutter board, (ii) an anchor and (iii) a tether that attaches the plug to the anchor, the cutter board includes slot in which the tether is received, below the surface of the board, and movement of the engagement pin from its extended toward its retracted position, after engagement with the plug, is effective to (i) release the plug from the second member, (iii) pull the plug through a hole formed by the device in the stapled tissue plication, and (iii) remove the tether from its slot in the cutter board. 
     
     
         6 . The improvement of  claim 5 , wherein the engagement pin and plug are designed to allow the pin to penetrate a portion of the plug, as the pin is moved toward its extended position, but prevent disengagement of the pin with the plug when the pin is moved toward its retracted position. 
     
     
         7 . The improvement of  claim 5 , wherein the device includes a membrane connecting the two members, defining a tissue-capture chamber therebetween, and an opening in the membrane through which tissue can be drawn into the chamber, under the influence of a vacuum applied to the chamber, the anchor in the anchor assembly is held releasably on the device outside the chamber, the tether connecting the plug to the anchor extends through the opening in the membrane, and movement of the engagement pin from its extended to retracted position, after engagement with the plug, is effective to (i) release the plug from the second member, (iii) pull the plug through a hole formed in the stapled tissue plication, (iii) remove the tether from its slot in the cutter board, and (iv) release the anchor from the device, wherein the device can be manipulated to pull the anchor through the hole in the stapled tissue plication after the stapled tissue plication has been released from the device. 
     
     
         8 . The improvement of  claim 7 , wherein the anchor includes a front, compressible cap joined to a back plate, and manipulating the device to pull the anchor through a hole in a staple tissue plication is effective to pull the cap through the hole, to engage one side of the fold, with the plate supported against the other side of the fold. 
     
     
         9 . The improvement of  claim 7 , wherein the device further includes means for severing the anchor-assembly tether, once the anchor is pulled through the hole in the stapled tissue plication. 
     
     
         10 . The improvement of  claim 7 , wherein the tether includes is designed to separate upon application of a predetermined pulling force applied to the tether. 
     
     
         11 . The improvement of  claim 7 , wherein the two members in the device are relatively movable toward one another to capture a tissue fold therebetween, and relatively movable away from one another to release a stapled tissue plication from the device, prior to manipulating the device to pull the anchor through the hole formed in the stapled tissue plication. 
     
     
         12 . The improvement of  claim 4 , wherein the anchor assembly includes a front, compressible cap joined to a flexible back plate, the anchor is carried releasably within the second-member housing, movement of the engagement pin from its retracted to extended position is effective to engage the anchor, and movement of the engagement pin from its extended toward its retracted position is effective to (i) release the anchor from the second-member housing, and (ii) pull the anchor cap through the hole in the stapled tissue placation formed by the device, to engage one side of the fold, with the anchor plate supported against the other side of the fold. 
     
     
         13 . The improvement of  claim 12 , wherein the second-member housing includes a central cavity having an opening surrounded by the cutter board and anvil, and the anchor assembly is releasably contained within said cavity. 
     
     
         14 . The improvement of  claim 13 , wherein said engagement pin includes means for releasing the anchor after the anchor's compressible cap has been pulled through the hole in the stapled tissue plication formed by the device. 
     
     
         15 . A method for forming a stapled tissue plication having placed therein, an anchor effective to attach an implant device to the tissue fold, comprising
 (a) capturing a tissue fold between two tissue-contact members,   (b) stapling the captured tissue so as to form a pattern of staples about an anchor zone,   (c) extending an engagement assembly through the anchor zone, before, during, or after said stapling step, to engage an anchor assembly,   (d) before, during or after said extending step, forming a hole in said anchor zone,   (e) retracting the engagement assembly and engaged anchor assembly to pull at least a portion of the anchor assembly through the hole at the tissue anchor zone, and   (f) releasing the stapled tissue from the tissue-contact members.   
     
     
         16 . The method of  claim 15 , wherein the engagement assembly includes an engagement pin, the anchor assembly includes a pin-engaging plug, an anchor having a front, compressible cap and a back plate, and a tether connecting the plug to the anchor, step (c) is effective to engage the pin with the plug, and step (e) is effective to pull the plug through the hole formed in the tissue in step (d). 
     
     
         17 . The method of  claim 16 , which further includes, following step (f), manipulating the engagement pin to pull the anchor cap through the hole formed at the anchor zone in the stapled tissue plication, to engage one side of the fold, with the anchor plate supported against the other side of the fold, and cutting the tether to release the stapled tissue plication with placed anchor from the pin and engaged plug. 
     
     
         18 . The method of  claim 17 , wherein the engagement assembly includes an engagement pin, the anchor assembly includes a front, compressible cap and a back plate, and a tether connecting the plug to the plate, step (c) is effective to engage the pin with the anchor, and step (e) is effective to pull the plug through the hole formed in the tissue in step (d), to engage one side of the fold, with the anchor plate supported against the other side of the fold, and which further includes disengaging the engagement pin from the anchor prior to releasing step (f).